Job title: Pharmacovigilance Case Quality Oversight Expert
- Location: Hyderabad
Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.
Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting.
At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.
B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet. Find out more about our mission at
www.opella.com
.
About the job:
Main responsibilities:
The PV Case Quality Oversight Expert is in charge to analyze Quality data related to ICSRs and to contribute to processes improvement related to Case Management (CM) & Medical evaluation.
- Responsible for ensuring ICSR submission compliance and ICSR quality compliance is achieved by performing oversight activities as applicable
- ICSR quality analytics and process related activities for case management
- Analyze in-process quality checks (QC), reporting of results, tracking quality findings, metrics against, defined KPIs and implement actions provided by Global PV case quality lead.
- Analyze ICSRs quality data of in-line workflow QCs/ off-line QCs (e.g., correction requests).
- Analyze quality deviations, identifying root causes, adjudicating ICSR corrections with corresponding issuance of CAPA, as appropriate, to evaluate CAPA effectiveness.
- Adjudicate findings accuracy.
- Drive continuous process improvement for CM by partnering with all entities, Country Safety Leads (CSL), License Partners, and vendors.
- Responsible to compare various quality metrics and provide comprehensive Quality analysis with action items
- Oversee Quality CAPA management for CM
- Investigate associated root causes and proposes CAPAs.
- Identify ICSRs trends, prepares, or coordinates preparation of ICSRs Quality report.
- Participate in CAPAs elaboration (e.g., trainings, QDs updates and user manual).
- Monitor CAPAs implementation and assess CAPAs effectiveness.
- Participate in vendor quality oversight activities, liaise regularly with vendors, and ensure quality consistency across CM functions.
- Lead or contribute to the Case quality review meetings for ICSRs where trends are presented, CAPAs proposed or discussed, efficiency assessed.
- Communicate analysis results to the CM / CSE PV community.
- Oversee the in-process workflow of all ICSRs and implementing strategies to prevent late ICSR reports.
- Create and maintain CAPA records to be provided for inspections/ audits.
- Review and create SOPs, job aids, etc for case management activities
- Other PV tasks as required.
About you
Experience:
- Experience in PV Databases like ARGUS, Aris-G (LSMV) VAULT Safety, etc.
- Overall 6+ years of experience, with minimum 5 years of pharmaceutical industry experience with a focus on pharmacovigilance
- Experience in case processing activities.
- Experience in handling Quality events, CAPA, Deviations
- Experience with QMS.
- Experience and understanding of the safety/pharmacovigilance process and regulations, ICH GVP and GxP regarding systems validation and documentation
- Good knowledge of MS Office
- Strong experience in ICSR quality review, submissions, CAPA, Deviation Management, RCA and trending analysis.
- Strong experience in effectives checks and trending analysis of the effectiveness check.
- Incumbent should have experience in Process Improvement practices
Soft skills:
- Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions.
- Attention to details, Analytic, pro-active and effective problem-solving skills. Excellent organizational and project management abilities.
- Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams.
- Excellent team-work and interpersonal skills
- Ability to work in cross-functional teams
- Excellent oral and written communication skills
- Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams.
Technical skills:
- Regulatory Standards: In-depth knowledge of global pharmacovigilance regulations and guidelines, such as those from the FDA, EMA, ICH, and other health authorities.
- Knowledge of how adverse events are reported and classified (e.g., by severity, outcome) and the regulatory requirements surrounding these reports
- Safety Reporting Requirements: Knowledge of regulatory requirements for safety reporting (e.g., CIOMS forms, EudraVigilance, FDA REMS, etc.) and experience in ensuring compliance with these standards.
- Good Pharmacovigilance Practices (GxP): Familiarity with GxP guidelines, ensuring that all pharmacovigilance processes adhere to industry standards.
- Database Management: Familiarity with safety databases and systems (e.g., Aris-G / LSMV, Argus Safety, VigiBase, or similar systems) used for collecting, analyzing, and reporting adverse event data.
- Microsoft Office Suite: Advanced skills in Excel (for data analysis and reporting), Word (for report writing), and PowerPoint (for presenting findings).
- Presentation Skills: Proficiency in presenting findings to mid-level management, stakeholders, or regulatory bodies in a clear and impactful way
Education:
Bachelor’s degree in pharmacy / Life Sciences / or equivalent Academic qualification is desirable with 5 years’ experience in PV Quality for case management
Why us?
At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.
We Are Challengers.
We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things:
All In Together: We keep each other honest and have each other's backs.
Courageous: We break boundaries and take thoughtful risks with creativity.
Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity.
Radically Simple: We strive to make things simple for us and simple for consumers, as it should be.
Join us on our mission. Health. In your hands.
www.opella.com/en/careers
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